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Develop and Validate Ultrasonic Device for Osteoporotic Fracture Risk Assessment (BUSS03)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01123421
Recruitment Status : Completed
First Posted : May 14, 2010
Last Update Posted : October 15, 2012
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Mayo Clinic
Information provided by (Responsible Party):
Artann Laboratories

Brief Summary:
Study to demonstrate that the Bone UltraSonic Scanner (BUSS) can aid in detection of osteoporosis and predict prevalent osteoporotic fractures. Measurements derived from the BUSS parameters will be able to discriminate between postmenopausal women with osteoporotic fractures when compared to matched controls without history of osteoporotic fracture.

Condition or disease
Osteoporosis Fracture Aging

Detailed Description:
One of several studies to develop and clinically validate a novel ultrasonographic device, BUSS, for the assessment of osteoporosis and fracture risk.

Study Type : Observational
Actual Enrollment : 113 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Portable Ultrasonometer for Osteoporosis Assessment: Retrospective Fracture Risk Validation Study, Version #1
Study Start Date : May 2010
Primary Completion Date : April 2011
Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
With osteoporotic fracture
Approximately 100 postmenopausal women that have been enrolled in a population-based case-control study that have experienced a clinically-diagnosed fracture of thoracolumbar spine or distal forearm due to minimal or moderate trauma based on review on their inpatient and outpatient medical records will be enrolled.
Without osteoporotic fracture
Approximately 100 control women will have no history of a prior spine, hip, or wrist fracture.



Primary Outcome Measures :
  1. Determine whether BUSS testing is equivalent or superior to DXA for fracture risk assessment in postmenopausal women. [ Time Frame: 1 year ]

Biospecimen Retention:   Samples Without DNA
Blood


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Both groups
Criteria

Inclusion Criteria:

  • postmenopausal women with osteoporotic fracture at spine or wrist
  • postmenopausal women no history of fracture at spine or wrist

Exclusion Criteria:

  • women with a history of metabolic disease
  • stroke
  • tibia fracture or surgery
  • BMI ≥ 35 kg/m2
  • Teriparatide use currently or within the past 6 months,
  • Any skin issues (open wounds or rashes, and/or skin infections) of the tibial area.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01123421


Locations
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Artann Laboratories
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Mayo Clinic
Investigators
Principal Investigator: Armen Sarvazyan, Ph.D., D.Sc. Artann Laboratories, Inc.

Responsible Party: Artann Laboratories
ClinicalTrials.gov Identifier: NCT01123421     History of Changes
Other Study ID Numbers: BUSS03
2R44AG017400 ( U.S. NIH Grant/Contract )
First Posted: May 14, 2010    Key Record Dates
Last Update Posted: October 15, 2012
Last Verified: October 2012

Keywords provided by Artann Laboratories:
osteoporosis
fracture risk
aging
tibia
sonometer
ultrasound
BMD
bone mineral density
DXA
3D-HRpQT
waveform profiles

Additional relevant MeSH terms:
Fractures, Bone
Osteoporosis
Osteoporotic Fractures
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases